# FDA 483 - Coapt LLC - December 11, 2019

Source: https://www.globalkeysolutions.net/records/483/coapt-llc/65fca4fa-18f0-4555-b2fc-1a785980131e

> FDA 483 for Coapt LLC on December 11, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Coapt LLC
- Inspection Date: 2019-12-11
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of Coapt LLC, a medical device manufacturer in Chicago, revealed significant deficiencies in their quality management system. The firm failed to adequately establish procedures for corrective and preventive actions, specifically regarding the verification and validation of CAPA effectiveness. Additionally, procedures for receiving, reviewing, and evaluating complaints were found to be inadequate, with issues in MDR reportability evaluations and complaint documentation.

## Related Documents

- [483 - 2022-11-02](https://www.globalkeysolutions.net/records/483/coapt-llc/af5464fa-05fd-4dfc-aa1b-f798c53b3ce3)

## Related Officers

- [Recall Coordinator](https://www.globalkeysolutions.net/people/emma-schaefer/10299982-dce6-4fea-a3e9-8167030b0331)

Company: https://www.globalkeysolutions.net/companies/coapt-llc/32959b76-e0c9-422d-92e7-d12579b7020c

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669